Crohn's DiseasePhase 3NCT00509639
Evaluation of Topical 10% Metronidazole Ointment for the Treatment of Active Perianal Crohn's Disease
A Phase 3 study testing 10% Metronidazole Ointment in people with Crohn's Disease, run by S.L.A. Pharma AG at 11 sites in 2 countries.
Trial summary
The purpose of this study is to compare changes in Perianal Crohn's Disease following use of locally applied 10% metronidazole ointment and a placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- 10% Metronidazole Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 11 sitesin 2 countries
- Study dates
- May 2005to Feb 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have Crohn's disease (diagnosed by radiology, endoscopy and pathology), with anorectal involvement.
- Have had perianal symptoms for longer than 3 months
- Have a PCDAI of 5 or above at baseline
- Subjects can be on concomitant medication. Acceptable regimes are:-
- Aminosalicylates at a dosage that has been stable for more than 4 weeks before screening;
- Oral corticosteroids <40mg per day that has been stable for more than 3 weeks;
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- Methotrexate given for at least 3 months that has been stable for more than 4 weeks; Azathioprine or mercaptopurine given for at least 6 months at dosage that has been stable for more than 8 weeks;
- Antibiotics at a dosage that has been stable for 4 weeks (subjects may be on oral metronidazole but on a dose not more than 750mg per day),
- Cycolsporin for more than 3 months and on a stable dose for more than 4 weeks;
- Patients who have been treated with Infliximab must have received their initial dose 3 months before starting study medication and their most recent dose at least 8 weeks before starting study medication and not receive an infusion whilst in the double-blind treatment phase of the study for 4 weeks. During the second 4 week open stage of the study patients can commence again a maintenance regime with Infliximab treatment if deemed necessary
- Any patients not on concurrent medication must have been off medication for at least 4 weeks before screening.
- If patients have Setons these must have been in place for at least 4 weeks prior to screening.
- Subjects must be aged 18 years or over and of the legal age of consent.
- If female, the subject must not be lactating and must be (a) post- menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use double- barrier methods of contraception (two separate methods of birthcontrol one of which may include oral contraception) for the duration of the study.
- Must have provided written informed consent to participate.
Who cannot join
- They have had surgery to the anus or rectum in the past 4 weeks;
- They have a perianal abscess requiring incision and drainage;
- They have a stoma of less than 6 months duration;
- Allergic to metronidazole;
- Are taking any prohibited medication.
- Deemed mentally incompetent.
- Considered by their physician unlikely to be able to comply with the protocol.
- Taken part in an experimental drug study in the preceding three months.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United Kingdom10 sites
Monklands Hospital
Airdrie, ML6 0JS
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Bristol Royal Infirmary
Bristol, BS1 3NU
University Hospital of Wales
Cardiff, CF14 4XW
University Hospital of Warwick and Coventry
Coventry, CV2 2DX
Derby City General Hospital
Derby, Derbyshire, DE22 3NE
St Marks Hospital
Harrow, HA1 3UJ
Leicester General Hospital
Leicester, Leicestershire, LE5 4PW
St Thomas Hospital
London, SE1 &EH
Peterborough District Hospital
Peterborough, PE3 6DA
United States1 site
Washington University School of Medicine
St Louis, Missouri, M 63110
About this study
Official title: Phase III Study to Evaluate the Effect of 10% Metronidazole Ointment, Applied Topically Three Times a Day in and Around the Anus and the Change in Perianal Crohn's Disease Activity
The purpose of this study is to compare changes in Perianal Crohn's Disease following use of locally applied 10% metronidazole ointment and a placebo.
Read the detailed description
Anorectal Crohn's disease is one of the most problematic and debilitating conditions encountered in colorectal practise. The condition is usually chronic, debilitating, and frequently refractory to current medications. Failure to respond to medical therapy may ultimately result in proctocolectomy and ileostomy, even in the absence of more proximal colonic disease. Isolated anorectal Crohn's disease is reported in 3 to 5% of Crohn's patients. In Crohn's patients as a whole, anorectal involvement is reported in up to one third to one half of patients, in addition to either colonic or enteric Crohn's disease. In spite of the previously reported painless nature of anorectal Crohn's disease, it is the author's experience that the condition can be inordinately painful due to deeply eroding fissures, oedematous skin tags, and painful induration of the perianal region.
- Conditions
- Crohn's Disease
- Being tested
- 10% Metronidazole Ointment
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% Metronidazole OintmentDrug
Metronidazole 10% ointment applied perianally three times daily for four weeks. Placebo ointment applied perianally three times daily for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole 10% ointment | Experimental | Metronidazole 10% ointment Receives: Drug: 10% Metronidazole Ointment |
| Placebo ointment | Placebo comparator | Placebo ointment Receives: Drug: 10% Metronidazole Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of 10% metronidazole ointment, applied topically three times a day, in and around the anus, on the change in perianal Crohn's disease activity.
Perianal Crohn's Disease Activity Index
Measured: Four weeks
Secondary outcomes (6)
To evaluate and compare the relief of perianal pain and discomfort associated with Crohn's disease, against placebo.
Perianal Crohn's Disease Activity Index plus Visual Analogue Scale for perianal pain
Measured: 4 weeks
To evaluate and compare Patient Global Impression of Improvement
Patient Global Impression of Improvement (numerical scale)
Measured: 4 weeks
To compare visual improvement (using photographic documentation assessed by a blinded independent observer)
Photographic record
Measured: 4 weeks
To compare Quality of Life assessments
Short Form 12 Questionnaire
Measured: 4 weeks
To evaluate and compare the number of analgesics required prior to treatment and to that required by the treatment and placebo group
Usage of analgesics during the treatment period
Measured: 4 weeks
To evaluate and compare fistula healing
Visual assessment of fistula healing
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startMay 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.L.A. Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emin Carapeti, BSc,MBBS,MD,, Principal investigator, St Thomas Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509639
- Sponsor's protocol ID
- MET/01
- Status last verified
- Dec 2012
- First submitted
- 30 Jul 2007
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Maeda Y, Ng SC, Durdey P, Burt C, Torkington J, Rao PK, Mayberry J, Moshkovska T, Stone CD, Carapeti E, Vaizey CJ; Topical Metronidazole in Perianal Crohn's Study Group. Randomized clinical trial of metronidazole ointment versus placebo in perianal Crohn's disease. Br J Surg. 2010 Sep;97(9):1340-7. doi: 10.1002/bjs.7121.
PubMed 20632322
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study to Evaluate the Effect of 10% Metronidazole Ointment, Applied Topically Three Times a Day in and Around the Anus and the Change in Perianal Crohn's Disease Activity
- ClinicalTrials.gov ID
- NCT00509639
- Acronym / sponsor ID
- MET/01
- Conditions
- Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- S.L.A. Pharma AGIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 31 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare changes in Perianal Crohn's Disease following use of locally applied 10% metronidazole ointment and a placebo.
Detailed description
Anorectal Crohn's disease is one of the most problematic and debilitating conditions encountered in colorectal practise. The condition is usually chronic, debilitating, and frequently refractory to current medications. Failure to respond to medical therapy may ultimately result in proctocolectomy and ileostomy, even in the absence of more proximal colonic disease. Isolated anorectal Crohn's disease is reported in 3 to 5% of Crohn's patients. In Crohn's patients as a whole, anorectal involvement is reported in up to one third to one half of patients, in addition to either colonic or enteric Crohn's disease. In spite of the previously reported painless nature of anorectal Crohn's disease, it is the author's experience that the condition can be inordinately painful due to deeply eroding fissures, oedematous skin tags, and painful induration of the perianal region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole 10% ointment | Experimental | Drug: 10% Metronidazole OintmentMetronidazole 10% ointment |
| Placebo ointment | Placebo comparator | Drug: 10% Metronidazole OintmentPlacebo ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Have Crohn's disease (diagnosed by radiology, endoscopy and pathology), with anorectal involvement.
- Have had perianal symptoms for longer than 3 months
- Have a PCDAI of 5 or above at baseline
- Subjects can be on concomitant medication. Acceptable regimes are:-
- Aminosalicylates at a dosage that has been stable for more than 4 weeks before screening;
Key exclusion criteria (8 listed)
- They have had surgery to the anus or rectum in the past 4 weeks;
- They have a perianal abscess requiring incision and drainage;
- They have a stoma of less than 6 months duration;
- Allergic to metronidazole;
- Are taking any prohibited medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% Metronidazole OintmentMetronidazole 10% ointment applied perianally three times daily for four weeks. Placebo ointment applied perianally three times daily for four weeks | Drug | Metronidazole 10% ointment, Placebo ointment |
Primary outcome
To evaluate the effect of 10% metronidazole ointment, applied topically three times a day, in and around the anus, on the change in perianal Crohn's disease activity.
Time frame: Four weeks
Perianal Crohn's Disease Activity Index
6 secondary outcomes
To evaluate and compare the relief of perianal pain and discomfort associated with Crohn's disease, against placebo.
Time frame: 4 weeks
To evaluate and compare Patient Global Impression of Improvement
Time frame: 4 weeks
To compare visual improvement (using photographic documentation assessed by a blinded independent observer)
Time frame: 4 weeks
To compare Quality of Life assessments
Time frame: 4 weeks
To evaluate and compare the number of analgesics required prior to treatment and to that required by the treatment and placebo group
Time frame: 4 weeks
To evaluate and compare fistula healing
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2012.
- Derived from this study: PubMed 20632322Maeda Y, Ng SC, Durdey P, Burt C, Torkington J, Rao PK, Mayberry J, Moshkovska T, Stone CD, Carapeti E, Vaizey CJ; Topical Metronidazole in Perianal Crohn's Study Group. Randomized clinical trial of metronidazole ointment versus placebo in perianal Crohn's disease. Br J Surg. 2010 Sep;97(9):1340-7. doi: 10.1002/bjs.7121.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emin Carapeti, BSc,MBBS,MD, principal investigator
St Thomas Hospital, London
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10% Metronidazole Ointment in people with Crohn's Disease, run by S.L.A. Pharma AG at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of 10% metronidazole ointment, applied topically three times a day, in and around the anus, on the change in perianal Crohn's disease activity. (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00509639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2012.